510(k) K922941

CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA by Clinical Neuro Systems, LLC — Product Code JXG

K922941 is an FDA 510(k) premarket notification submitted by Clinical Neuro Systems, LLC for the device "CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA". The FDA issued a decision of Substantially Equivalent on August 26, 1992. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Clinical Neuro Systems, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1992
Date Received
June 18, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type